A phase II study of extended-field proton therapy alone after with or without endoscopic submucosal dissection for patients with superficial esophageal cancer

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0004853

Enrollment

Registered

2020-03-24

Start date

2018-04-11

Completion date

Unknown

Last updated

2020-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Radiation : [Proton beam therapy scheme] 1. Clinical Target Volume (CTV) 2: whole esophagus + mediastinum + SCL + perigastric LN area (right) + celiac LN area 2. CTV1: primary tumor + safety margin

of CTV coverage or &gt

=95&#37

of PTV coverage 6. Dose prescription: 44 Gy/ 22 fractions (2.0Gy/fraction/day, 5 times/week) to PTV2 and followed by 6-22 Gy/ 8-11 fractions (2.0Gy/fraction/day, 5 times/week) to PTV1

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - histologically proven thoracic or gastroesophageal junctional superficial esophageal cancer - no evidence of lymph node metatasis in endoscopic US, chest CT, and PET-CT - ECOG performance status 0-2 - cT1N0 - one of those among lymphovascular invasion (+), submucosal invasion (+) or positive vertical resection margin in submucosal dissection specimen - unresectable lesion with submucosal dissection, but patient refused to undergo curative surgery - Informed consent

Exclusion criteria

Exclusion criteria: - Recurrent esophageal cancer - a history of previous treatment for esophageal cancer including local or systemic therapy - presence of other malignancies except cured skin squamous cell carcinoma, skin basal cell carcinoma and carcinoma in situ in uterine cervix. - Uncontrolled mental illness, severe head trauma, chronic alcoholics or drug addictions

Design outcomes

Primary

Measure	Time frame
progression-free survival	—

Secondary

Measure	Time frame
overall survival;Treatment-related toxicity rate	—

Countries

Korea, Republic of

Contacts

Public ContactSung Ho Moon

National Cancer Center

Outcome results